F.D.A. Approves a Pill for Lung Cancer to Be Sold by Genentech and OSI

By ANDREW POLLACK

Published: November 19, 2004

The approval by the Food and Drug Administration came well before the agency's late-January deadline, making it one of the fastest drug approvals ever.

Tarceva was approved for patients with advanced non-small cell lung cancer, the most common form of the disease, who have failed to respond to at least one prior attempt to use chemotherapy. Analysts expect annual sales of the drug to eventually reach hundreds of millions of dollars, perhaps more than $1 billion.

The drug is expected to compete most directly with AstraZeneca's Iressa, a similar drug that was approved in 2003. Tarceva's advantage is that in a clinical trial it was shown to prolong lives, by a median of 6.7 months compared to 4.7 months for patients who got a placebo. So far, Iressa has only been shown to shrink tumors.

Both drugs, as well as ImClone Systems' colon cancer drug, Erbitux, try to block a particular protein, the epidermal growth factor receptor, that spurs the growth of cancer cells.

Such so-called targeted drugs tend to have fewer side effects than conventional chemotherapy. The main side effects of Tarceva are a rash and diarrhea, although there have been infrequent reports of serious or even fatal lung disease in patients taking the drug.

Tarceva might also compete with Alimta from Eli Lilly and Taxotere from Aventis, both approved second treatments for lung cancer.

Tarceva, a pill taken once a day, will be priced at slightly more than $2,000 wholesale for a month's supply, said Colin Goddard, chief executive of OSI.

Patients and doctors have complained recently about the high prices of cancer drugs. Dr. Goddard defended the price of Tarceva, saying it was ''set competitively against the other drugs in play.'' He said the drug was priced at a few hundred dollars more per month than Iressa but less than many other cancer drugs.

In another clinical trial, Tarceva was found to extend the lives of patients with pancreatic cancer, which is extremely difficult to treat. The companies plan to apply for approval for that use next year, Dr. Goddard said.

OSI initially came up with the drug, and licensed marketing rights to Genentech and Roche, the Swiss company that owns a majority of Genentech. Genentech, with help from OSI, will sell the drug in the United States, while Roche will handle sales overseas. Approval in Europe is expected around the middle of next year.

Tarceva is the fourth Genentech drug -- and the second one for cancer -- approved in the last two years. Genentech, which is the second-biggest biotechnology company after Amgen, has set a goal of becoming the largest supplier of cancer drugs.

Tarceva did not work when tested in combination with chemotherapy as an initial treatment for lung cancer. That would have been a bigger potential market than treatment of patients who fail to respond to chemotherapy.